Clinical trials with direct oral anticoagulants for stroke prevention in atrial fibrillation: how representative are they for real life patients?

Purpose To identify the proportion of real-life patients with atrial fibrillation (AF) eligible for direct oral anticoagulant (DOAC) therapy, based on the inclusion and exclusion criteria used in the clinical studies and based on the officially approved indications as mentioned in the Summary of Pro...

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Bibliographic Details
Published in:European journal of clinical pharmacology 2016-09, Vol.72 (9), p.1125-1134
Main Authors: Desmaele, S., Steurbaut, S., Cornu, P., Brouns, R., Dupont, A. G.
Format: Article
Language:English
Subjects:
Administration, Oral
Aged
Aged, 80 and over
Anticoagulants - therapeutic use
Atrial Fibrillation - drug therapy
Biomedical and Life Sciences
Biomedicine
Cardiac arrhythmia
Clinical trials
Clinical Trials as Topic
Dabigatran - therapeutic use
Female
Humans
Male
Middle Aged
Pharmacoepidemiology and Prescription
Pharmacology
Pharmacology/Toxicology
Psychotropic drugs
Pyrazoles - therapeutic use
Pyridones - therapeutic use
Rivaroxaban - therapeutic use
Stroke
Stroke - prevention & control
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Summary:Purpose To identify the proportion of real-life patients with atrial fibrillation (AF) eligible for direct oral anticoagulant (DOAC) therapy, based on the inclusion and exclusion criteria used in the clinical studies and based on the officially approved indications as mentioned in the Summary of Product Characteristics (SmPC). Methods Data for this retrospective cross-sectional study was extracted from the UZ Brussel Stroke Registry, containing anonymized data of 2205 patients with a suspected stroke. Characteristics of patients with documented AF were compared with the patient characteristics in clinical trials and the approved indications in the SmPC. Results Data of 468 patients with AF was analyzed. Based on the selection criteria of the clinical trials, significantly less patients were eligible for treatment with rivaroxaban compared to dabigatran etexilate (39.3 versus 47.6 %; p  = 0.010), but not compared to apixaban (45.5 %; p  = 0.055). Based on the indications and contraindications in the SmPC, significantly fewer patients were eligible for apixaban compared to dabigatran etexilate and rivaroxaban (62.0 % for apixaban, 72.9 % for dabigatran etexilate, and 75.6 % for rivaroxaban; p  
ISSN:0031-6970
1432-1041
DOI:10.1007/s00228-016-2078-1